Replies to post #106512 on Biotech Values

[DewDiligence]

The fact that TEVA has decided to hire a former senior level FDA Scientist as their US regulatory affairs VP suggests that they are unhappy with the progress on their reviews at the FDA.

That’s a reasonable inference, FL. However, when it comes to Lovenox, even a first-rate regulatory-affairs executive cannot simply wave a wand to make a deficient drug compliant.

[jbog]

Flatlander

The fact that TEVA has decided to hire a former senior level FDA Scientist as their US regulatory affairs VP suggests that they are unhappy with the progress on their reviews at the FDA. I believe that this may be a signal that they feel the need for more regulatory liaison capabilities in the US. This may be a direct outgrowth of their Lovenox ANDA being stuck in the mud for so long.

Teva has somewhere in the area of 170 individual product ANDA'S sitting at the FDA. To think that lovenox is their main contention is probably a stretch.

Teva's #1 goal would be to protect their MS franchise when dealing with the FDA, so I'd look to see if this could be their motive.